The Efficacy of Transarterial Chemoinfusion (TAI) Combine Toripalimab in Advanced Hepatocellular Carcinoma (HCC)

NCT ID: NCT03851939

Last Updated: 2019-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2021-03-01

Brief Summary

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To evaluate the efficacy of TAI combine toripalimab in advanced HCC.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment group

Transarterial Chemoinfusion (TAI) Combine Toripalimab

Group Type EXPERIMENTAL

Transarterial Chemoinfusion (TAI) Combine Toripalimab

Intervention Type COMBINATION_PRODUCT

Transarterial Chemoinfusion (TAI) Combine Toripalimab

Interventions

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Transarterial Chemoinfusion (TAI) Combine Toripalimab

Transarterial Chemoinfusion (TAI) Combine Toripalimab

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* older than 18 years old and younger than 75 years;
* ECOG PS≤1;
* proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
* not previous treated for tumor;
* cannot accepted hepatectomy;
* the lab test could meet:

* neutrophil count≥2.0×109/L;
* hemoglobin≥100g/L;
* platelet count≥75×109/L;
* serum albumin≥35g/L;
* total bilirubin\<2-times upper limit of normal;
* ALT\<3-times upper limit of normal;
* AST\<3-times upper limit of normal;
* serum creatine\<1.5-times upper limit of normal;
* PT≤upper limit of normal plus 4 seconds;
* INR≤2.2;
* sign up consent;

Exclusion Criteria

* cannot tolerate TAI or toripalimab;
* known history of other malignancy;
* be allergic to related drugs;
* underwent organ transplantation before;
* be treated before (interferon included);
* known history of HIV infection;
* known history of drug or alcohol abuse;
* have GI hemorrhage or cardiac/brain vascular events within 30 days;
* pregnancy;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Rong-ping Guo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shaohua Li, MD

Role: CONTACT

+8615088064187

Facility Contacts

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Rong-Ping Guo, M.D.

Role: primary

00862087342266

Wei Wei, Ph.D. M.D.

Role: backup

00862087343790

Other Identifiers

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B2018-158-01

Identifier Type: -

Identifier Source: org_study_id

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